FDA.reportPublic FDA data

Restoration

Primary DI
07613153071358
Brand
Restoration
Company
Howmedica Osteonics Corp.
Model
6276-2-119
Catalog number
6276-2-119
Device description
Modular Hip System
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented
KWLProsthesis, hip, hemi-, femoral, metal
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
KWZProsthesis, hip, constrained, cemented or uncemented, metal/polymer
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LWJProsthesis, hip, semi-constrained, metal/polymer, uncemented
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
MAYProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
MBLProsthesis, hip, semi-constrained, uncemented, metal/polymer, porous
MEHProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
KWLProsthesis, Hip, Hemi-, Femoral, MetalOrthopedic2
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MAYProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic FinishOrthopedic2
MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, PorousOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613153071358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613153071358076131530713587613153071358

GMDN Terms#

Term, Definition table
TermDefinition
Press-fit femoral stem prosthesisA sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel].

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
058311945
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327027730Triathlon5610-F-1015610-F-1012015-09-24
07613327027747Triathlon5610-F-2015610-F-2012015-09-24
07613327027754Triathlon5610-F-1025610-F-1022015-09-24
07613327027761Triathlon5610-F-2025610-F-2022015-09-24
07613327027778Triathlon5610-F-3015610-F-3012015-09-24
07613327027785Triathlon5610-F-3025610-F-3022015-09-24
07613327027792Triathlon5610-F-4015610-F-4012015-09-24
07613327027808Triathlon5610-F-4025610-F-4022015-09-24
07613327027815Triathlon5610-F-5025610-F-5022015-09-24
07613327027822Triathlon5610-F-6015610-F-6012015-09-24
07613327027839Triathlon5610-F-6025610-F-6022015-09-24
07613327027846Triathlon5610-F-5015610-F-5012015-09-24
07613327207163INSTRUMENT5510-T-1015510-T-1012016-09-24
07613327208832INSTRUMENT1100-12251100-12252016-09-24
07613327012804V40 Head6260-4-2226260-4-2222015-09-24
07613327012811V40 Head6260-4-3226260-4-3222015-09-24
07613327012828V40 Head6260-5-0266260-5-0262015-09-24
07613327012835V40 Head6260-5-0286260-5-0282015-09-24
07613327012842V40 Head6260-5-0326260-5-0322015-09-24
07613327012859V40 Head6260-5-1266260-5-1262015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024707160G7® Vivacit-E®Zimmer, Inc.LPH2026-09-30
00889024707160G7® Vivacit-E®Zimmer, Inc.JDI2026-09-30
00889024707160G7® Vivacit-E®Zimmer, Inc.LZO2026-09-30
00889024707177G7® Acetabular SystemBiomet Orthopedics, LLCLPH2026-09-30
00889024707177G7® Acetabular SystemBiomet Orthopedics, LLCJDI2026-09-30
00889024707177G7® Acetabular SystemBiomet Orthopedics, LLCLZO2026-09-30
00889024707184G7® Vivacit-E®Zimmer, Inc.LPH2026-09-30
00889024707184G7® Vivacit-E®Zimmer, Inc.JDI2026-09-30
00889024707184G7® Vivacit-E®Zimmer, Inc.LZO2026-09-30
00889024707191G7® Acetabular SystemBiomet Orthopedics, LLCLZO2026-09-30
00889024707191G7® Acetabular SystemBiomet Orthopedics, LLCJDI2026-09-30
00889024707191G7® Acetabular SystemBiomet Orthopedics, LLCLPH2026-09-30
00889024707207G7® Vivacit-E®Zimmer, Inc.LPH2026-09-30
00889024707207G7® Vivacit-E®Zimmer, Inc.JDI2026-09-30
00889024707207G7® Vivacit-E®Zimmer, Inc.LZO2026-09-30
00889024707214G7® Acetabular SystemBiomet Orthopedics, LLCLPH2026-09-30
00889024707214G7® Acetabular SystemBiomet Orthopedics, LLCLZO2026-09-30
00889024707214G7® Acetabular SystemBiomet Orthopedics, LLCJDI2026-09-30
07613327208832INSTRUMENTHowmedica Osteonics Corp.KWL2016-09-24
07613327208832INSTRUMENTHowmedica Osteonics Corp.JDI2016-09-24
07613327208832INSTRUMENTHowmedica Osteonics Corp.KWZ2016-09-24
07613327208832INSTRUMENTHowmedica Osteonics Corp.LZO2016-09-24
07613327208832INSTRUMENTHowmedica Osteonics Corp.MBL2016-09-24
07613327208832INSTRUMENTHowmedica Osteonics Corp.MAY2016-09-24
07613327208832INSTRUMENTHowmedica Osteonics Corp.LWJ2016-09-24
07613327208832INSTRUMENTHowmedica Osteonics Corp.KWY2016-09-24
07613327208832INSTRUMENTHowmedica Osteonics Corp.MEH2016-09-24
07613327208832INSTRUMENTHowmedica Osteonics Corp.LPH2016-09-24
07613327012804V40 HeadHowmedica Osteonics Corp.KWL2015-09-24
07613327012804V40 HeadHowmedica Osteonics Corp.LPH2015-09-24